Vomiting :: FDA approves first medication to treat and prevent vomiting in dogs

Pfizer Animal Health (PAH) announced the U.S. Food and Drug Administration (FDA) has approved Cerenia(TM) (maropitant citrate), the first medication to prevent and treat acute vomiting in dogs.

This first-in-class drug has been proven to be a safe and effective medication that veterinarians can use to control emesis (vomiting), quickly and effectively, regardless of the cause, including motion sickness.

Vomiting is one of the most common reasons owners take their dogs to the veterinarian. According to Pfizer Animal Health market research, veterinarians see on average 30 cases of vomiting per month, with an estimated 2.8 million dogs experiencing vomiting each year in the U.S. In addition, another 1.2 million dogs suffer from vomiting caused by motion sickness.

While distressing to both dog and owner, vomiting may also be a sign of a serious underlying problem. To date, there is no product developed and approved specifically to treat and prevent vomiting in dogs.

While there are two pathways that cause vomiting in dogs, central and peripheral, veterinarians mainly rely on human-labeled products that address only a single pathway. This can often lead to inconsistent treatment results and frustration for owner and veterinarian. Cerenia is unique because it prevents and treats canine vomiting regardless of the pathway involved.

“In many cases it is important to treat vomiting in order to prevent further deterioration of the dog’s health and to alleviate suffering,” said S. Kristina Wahlstrom, VMD, MS, group director, U.S. Companion Animal Veterinary Operations, Pfizer Animal Health. “Current treatments may not be effective depending on the pathway involved, resulting in unnecessary distress to the dog and owner.”

Cerenia addresses an unmet need in veterinary medicine. The product is administered once daily, unlike many human-labeled drugs that are often dosed as many as two to four times per day. Available in both injectable and tablet formulations, Cerenia starts to work within one hour of administration. Cerenia will be available by prescription only from veterinarians in the summer 2007.

“This has been an exciting year for veterinarians and their canine patients with the approval of two first-in-class medications to treat and manage serious medical conditions,” said George Fennell, vice president, U.S. Companion Animal, Pfizer Animal Health. “Both medications — the first drug to manage canine obesity and now the first treatment for canine vomiting — demonstrate Pfizer’s commitment to provide innovative and groundbreaking medications that will help dogs lead longer, healthier lives.”

Pfizer researchers and veterinarians spent seven years conducting the research and development leading to the approval of Cerenia. In clinical trials involving 577 dogs, Cerenia was shown to be safe and effective, producing consistent results in a wide range of dog breeds and causes of vomiting such as parvovirus, gastroenteritis and renal disease.

Cerenia is generally well tolerated by dogs. Side effects observed include excessive salivation, vomiting and muscle tremors. Cerenia has not been evaluated in dogs used for breeding, pregnant or lactating bitches, dogs with gastrointestinal obstruction, or dogs that have ingested toxins. Cerenia is recommended for use in dogs 16 weeks of age and older. Cerenia should be used with caution in dogs with hepatic dysfunction and with other medications that are highly protein bound. Cerenia is not for use in humans.

With 2006 sales of $2.3 billion, Pfizer Animal Health is a global leader in discovering, developing and marketing medicines and vaccines for companion animals and livestock, including beef and dairy cattle and swine.

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